(190 days)
The ZIO® SR ECG Monitoring Service is intended to capture, and report symptomatic and/or continuous electrocardiogram (ECG) information for long-term monitoring (up to 14 days). It is indicated for use on adult patients 18 years or older who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, syncope, fatigue, or anxiety. The reported ECG metrics include single-lead analysis on a beat by beat basis, heart rate measurement and rhythm analysis. The report does not contain diagnostic interpretation; the reported analysis is provided for review by the intended user to render a diagnosis based on clinical judgment and experience.
The ZIO® SR ECG Monitoring Service consists of three components: (1) ZIO SR Patch Recorder with Bluetooth technology, (2) ZIO SR Wireless Gateway, and (3) ZIO ECG Utilization Service System.
The ZIO® SR Patch is a single-patient-use ECG monitor that provides a continuous, singlechannel recording in addition to symptomatic data transmission for up to 14 days. The ZIO® SR Patch records ECG without patient interaction, with the goal of improving patient compliance via simplicity of operation. Patients have the option of pressing a convenient trigger button which marks the continuous record and initiates a wireless transfer of an ECG strip of 90-second duration. The wireless transfer of data is enabled by the ZIO® SR Gateway, which requires proximity and reception but no patient interaction. The patient is encouraged to fill out a log to document symptomatic events, which will support symptom-rhythm correlation in the ZIO SR Report. Alternatively, the patient can enter symptom logs and view received transmissions via an online patient portal.
At the conclusion of the wear period (up to 14 days), the patient removes the ZIO® SR Patch and returns it by mail to an iRhythm data processing center.
Upon receipt of symptomatic or continuous ECG data at iRhythm's Clinical Center (iCC) the ECG data is downloaded, the data is processed through the algorithm and delivered to the QA Tool module where the results are reviewed and/or adjusted by iRhythm Certified Cardiographic Technicians (CCT's) for accuracy. iRhythm employed and trained Patch in-take and CCT personnel follow internal procedures for processing and are of algorithm performance anomalies. Any software anomalies are visible to and manually corrected by iRhythm Technologies CCT's during the QA review and/or Patch Report edits. The CCT generates a final report of the ECG findings contained within the data; thereby enabling the provision of a complete ECG processing and analysis service.
Upon explicit request from a clinician responsible for the patient's healthcare, longer segments of ECG data from the continuous recording on the Patch can also be wirelessly retrieved during the wear period.
Automated ECG analysis performance was quantified for any claimed analysis metrics. The resulting statistics demonstrate sensitivity and positive predictivity levels which satisfy requirements and minimize safety or efficacy concerns.
Here's a breakdown of the acceptance criteria and study information based on the provided text, recognizing that certain specific details (like exact performance metrics or sample sizes for specific training sets) are not explicitly stated in this 510(k) Summary document but can be inferred or acknowledged as missing from this specific submission.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Automated ECG Analysis Performance for Analysis Metrics | Satisfy requirements to minimize safety or efficacy concerns. | "The resulting statistics demonstrate sensitivity and positive predictivity levels which satisfy requirements and minimize safety or efficacy concerns." (Specific numerical targets for sensitivity and positive predictivity are not provided in this document.) |
| All Necessary Performance Testing (covering areas like electrical safety, EMC, biocompatibility) | Met requirements of recognized consensus standards (listed below). | "All necessary performance testing was conducted on the ZIO® SR ECG Monitoring Service to support determination of substantial equivalence to the predicate devices. The results confirm by examination and provision of objective evidence that the design output met the design input requirements in conformance with the following list of recognized consensus standards." |
List of Recognized Consensus Standards (which define performance requirements):
- ISO 14971:2007/(R)2010 (Medical devices - applications of risk management)
- IEC 60601-1:2005/(R)2012 and A1:2012, c1:2009/(r)2012 and a2:2010/(r)2012 (Medical electrical equipment - general requirements for basic safety and essential performance)
- IEC 60601-1-2:2007 (Medical electrical equipment - electromagnetic compatibility)
- IEC 60601-1-11 Edition 1.0 2010-04 (Medical electrical equipment - requirements for home healthcare environment)
- IEC 60601-2-47:2012 (Medical electrical equipment - requirements for ambulatory electrocardiographic systems)
- EC12:2000/(R)2010 (Disposable ECG electrodes)
- ISO 10993-1:2009/(R) 2013 (Biological evaluation of medical devices - biocompatibility)
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in the provided text. The document refers to "Automated ECG analysis performance was quantified for any claimed analysis metrics" but does not give a specific number of records or patients/recordings used for the test set.
- Data Provenance: Not explicitly stated in the provided text. It does not mention the country of origin or whether the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not explicitly stated for the test set ground truth establishment.
- Qualifications of Experts: The document mentions that the results of the algorithm are reviewed and/or adjusted by "iRhythm Certified Cardiographic Technicians (CCT's) for accuracy." While these CCTs perform review and correction of general algorithm output, it's not explicitly stated if they were the ones establishing the gold standard/ground truth for the test set used to validate the algorithm itself, or if a different set of more senior experts (e.g., cardiologists) were involved in creating the ground truth for an independent test set.
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly stated for the test set ground truth establishment. The document describes a post-processing step where "results are reviewed and/or adjusted by iRhythm Certified Cardiographic Technicians (CCT's) for accuracy" in the Clinical Center. This sounds like an internal quality assurance step, but not necessarily the method for establishing a blinded, adjudicated ground truth for a formal validation study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, the provided text does not describe a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance. The described process involves CCTs reviewing and potentially adjusting the algorithm's output, implying a form of human-in-the-loop, but not a formal comparative effectiveness study as typically defined for MRMC.
- Effect Size of Improvement: Since no MRMC study is described, no effect size of human reader improvement with AI assistance is provided.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Yes, standalone algorithm performance appears to have been evaluated. The text states: "Automated ECG analysis performance was quantified for any claimed analysis metrics. The resulting statistics demonstrate sensitivity and positive predictivity levels which satisfy requirements and minimize safety or efficacy concerns." This strongly suggests a standalone evaluation of the algorithm's output before any human review or adjustment.
7. The Type of Ground Truth Used
- Type of Ground Truth: The document implies an expert consensus or expert review process for establishing ground truth, as it mentions CCTs reviewing and adjusting algorithm output for accuracy. However, it's not explicitly stated whether this was strictly expert consensus from multiple independent reviewers, or a single expert's review, or another form of ground truth like pathology or outcomes data. Given the "CCT's for accuracy" statement, it leans towards expert review.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not explicitly stated in the provided text.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment for Training Set: Not explicitly stated in the provided text. The document focuses on the operational workflow and validation of the device, not the specifics of the AI model training data or its annotation process.
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).